Last updated: July 30, 2025
Introduction
The drug with NDC (National Drug Code) 60505-2676 represents a pharmaceutical product within the United States market. Precise analysis of its market dynamics and pricing trajectories is vital for stakeholders—including pharmaceutical companies, healthcare providers, investors, and policymakers—to inform strategic decisions. This report explores current market factors, competitive landscape, regulatory influences, pricing trends, and future projections specific to NDC 60505-2676.
Product Overview
The NDC 60505-2676 corresponds to Daratumumab (Darzalex), a monoclonal antibody developed by Janssen Pharmaceutical Companies, primarily indicated for the treatment of multiple myeloma. Since its FDA approval in 2015, Daratumumab has become a cornerstone in multiple myeloma management, owing to its novel mechanism of action targeting CD38.
Market Landscape
1. Market Size and Growth Dynamics
The multiple myeloma therapeutic market has experienced significant expansion driven by increasing disease prevalence, advances in treatment options, and rising awareness. In 2022, the global multiple myeloma drug market was valued at approximately $14 billion, with projections to reach $20 billion by 2028, reflecting a CAGR of around 6.5%. The U.S. market contributed an estimated 45% of this revenue, with continued growth expected as broader patient populations gain access to novel treatments.
2. Competitive Environment
Daratumumab competes with other anti-CD38 therapies—such as Isatuximab (Sanofi), which received FDA approval in 2020, and emerging bispecific antibodies. The key competitors also include established agents like Bortezomib, Lenalidomide, and Pomolidomide-based regimens. The competitive landscape remains intense, with ongoing clinical trials introducing second-generation agents and combination therapies that could influence market share and pricing.
3. Key Market Drivers
- Efficacy and Safety Profile: Clinical trials demonstrate Daratumumab’s superior efficacy in relapsed/refractory multiple myeloma, supporting widespread adoption.
- Regulatory Approvals: Expansion of indications, including newly approved combination protocols, broadens market access.
- Reimbursement Policies: Favorable payer coverage, supported by substantial evidence of clinical benefits, enhances market penetration.
- Patient Demand for Targeted Therapies: Growing preference for monoclonal antibodies and personalized medicine fuels demand.
4. Market Penetration and Adoption
Daratumumab adoption has been rapid since launch. By 2022, approximately 70% of eligible multiple myeloma patients in the U.S. received Daratumumab-containing regimens. The drug's inclusion in multiple treatment guidelines and high reimbursement rates underpin its market penetration.
Pricing Analysis
1. Current Price Points
The wholesale acquisition cost (WAC) for Daratumumab (NDC 60505-2676) remains in the approximate range of $4,800 – $6,000 per 20 mg vial. The typical regimens involve multiple doses, leading to an average treatment course costing $60,000 – $120,000 annually per patient, depending on dosage, frequency, and combination therapy.
2. Pricing Trends
- Post-Launch Price Stability: Prices for Daratumumab have remained relatively stable since market entry, with minor adjustments due to inflation and manufacturing costs.
- Payer Negotiations: Payers have exerted influence through formulary negotiations, reducing net prices via rebates and discounts.
- Market Competition Influence: Introduction of biosimilars or alternative therapies could pressure price reductions over time; however, as of early 2023, Daratumumab remains a first-line agent with limited direct biosimilar competition.
3. Reimbursement and Cost-Effectiveness
Economic evaluations, including cost-effectiveness analyses, typically support Daratumumab’s pricing by demonstrating improved survival outcomes relative to older regimens. Payers often favor coverage for high-efficacy treatments, reinforcing stable reimbursement rates.
Future Price Projections
1. Short-Term Outlook (Next 2–3 Years)
- Price Remains Stable: Given the predominance of Daratumumab in treatment protocols, prices are likely to hold steady, barring significant policy changes or patent challenges.
- Potential for Slight Discounts: Payer-driven rebates and value-based contracting could result in marginal net price reductions.
2. Medium to Long-Term Outlook (3–7 Years)
- Introduction of Biosimilars: Patent expirations or legal challenges—expected around 2025—may pave the way for biosimilars, exerting downward pressure on list and net prices.
- Combination Therapies and New Indications: Expanded approvals could alter pricing strategies, possibly leading to premium pricing for combination regimens.
- Market Saturation and Innovation: As newer agents with potentially superior safety or efficacy profiles enter the market, Daratumumab’s pricing may need to adjust downward to maintain competitiveness.
3. External Factors Impacting Pricing
- Regulatory Changes: Policy shifts favoring cost reductions or alternative payment models may effectuate price adjustments.
- Reimbursement Trends: Payer willingness to reimburse high-cost biologics depends heavily on demonstrated value and long-term outcomes.
- Global Market Dynamics: International markets often negotiate lower prices; global procurement trends can influence U.S. pricing strategies indirectly.
Strategic Implications for Stakeholders
- Pharmaceutical Manufacturers: Emphasize lifecycle management through indication expansion and combination regimens to sustain revenue streams.
- Healthcare Providers: Optimize treatment protocols to maximize cost-effectiveness within reimbursement constraints.
- Investors: Monitor patent statuses and biosimilar developments to anticipate price erosion timelines.
- Policymakers: Balance access and innovation incentives through pricing and reimbursement policies.
Key Takeaways
- Daratumumab (NDC 60505-2676) is a leading monoclonal antibody in multiple myeloma treatment, commanding stable but premium pricing driven by clinical efficacy.
- The market is expanding but increasingly competitive, with biosimilar entry on the horizon around 2025-2026 projected to impact pricing.
- Current prices range from $4,800 to $6,000 per vial, with annual treatment costs averaging $60,000–$120,000.
- Future pricing will be influenced by biosimilar competition, indication expansions, treatment regimens, and regulatory policies.
- Stakeholders must develop adaptive strategies considering impending patent expirations, emerging therapies, and evolving payer dynamics.
FAQs
Q1: When is the patent for Daratumumab expected to expire, and how will biosimilars impact pricing?
A1: The primary patent protection for Daratumumab is expected to expire around 2025-2026. The entry of biosimilars thereafter will likely lead to significant price reductions, potentially 20-40%, depending on market competition and regulatory approval pathways.
Q2: Are there any current discounts or rebate programs affecting the net price of NDC 60505-2676?
A2: Yes. Payers and pharmacy benefit managers negotiate rebates and discounts, resulting in net prices often lower than the list WAC. These arrangements vary by payer and are typically confidential, but they significantly influence actual market pricing.
Q3: How do clinical guidelines influence the pricing and utilization of Daratumumab?
A3: Inclusion in treatment guidelines (e.g., NCCN, ASH) enhances utilization, supporting sustained demand and justifying current prices. As the drug remains a standard of care, its value proposition remains high, supporting stable pricing.
Q4: What are the potential effects of new combination therapies on Daratumumab's market share?
A4: New combination treatments, especially those demonstrating superior efficacy or safety, may cannibalize Daratumumab’s market share, leading to adjustments in pricing strategies to remain competitive or incentivize formulary placement.
Q5: How are global market prices for Daratumumab different from U.S. prices?
A5: International prices tend to be lower due to price regulation, competitive bidding, and differing reimbursement policies. Variations influence global market strategy and can indirectly affect U.S. pricing strategies through supply chain considerations and patent challenges.
Sources
- MarketWatch. Global Multiple Myeloma Drug Market Analysis, 2022.
- FDA. Daratumumab (Darzalex) Approval and Indications, 2015.
- ICER. Cost-Effectiveness of Daratumumab, 2021.
- Janssen Pharmaceuticals. Product prescribing information.
- Pharma Intelligence. Biosimilar entry timelines and patent expirations, 2022.
Disclaimer: The insights provided are for informational purposes only. Stakeholders should corroborate with the latest regulatory filings, market reports, and clinical guidelines before strategic decision-making.
